Study of Medication Adherence to Aromatase Inhibitors With or Without Abemaciclib in Adult Women With Early HRHER2- Breast Cancer
Led by Institute of Oncology Ljubljana · Updated on 2026-03-06
319
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are examining medication adherence in women with early-stage hormone receptor-positive, HER2-negative breast cancer. This study compares adherence rates between patients treated with aromatase inhibitors alone and those receiving aromatase inhibitors combined with the CDK46 inhibitor abemaciclib. The study aims to understand how factors like quality of life, cognitive function, attitudes toward therapy, age, and prior treatments influence adherence and treatment discontinuation.
Participants include adult women already prescribed aromatase inhibitors with or without abemaciclib as part of their routine care. The study observes these patients over time without altering their prescribed treatments. Two groups are followed one receiving both aromatase inhibitors and abemaciclib, and the other receiving only aromatase inhibitors. Treatment adherence and discontinuation are tracked during this observational period.
Participants will complete quality of life questionnaires EORTC QLQ-C30 and QLQ-BR23, beliefs about medicines surveys, and cognitive function tests FACT-Cog at the start of the study and again at 3 and 6 months after treatment begins. Medication adherence is measured at 3 and 6 months using the Proportion of Days Covered method. Adverse events are monitored throughout the 6-month follow-up. The study is conducted with adult women receiving treatment at the Institute of Oncology Ljubljana, and participation involves providing informed consent and completing scheduled assessments.
CONDITIONS
Brief Title
Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Research Team
E
Erika Matos, PhD
C
Cvetka Grašič Kuhar, PhD
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Diagnosed with early hormone receptor-positive, HER2-negative breast cancer
Receiving adjuvant therapy with an aromatase inhibitor (letrozole, anastrozole, or exemestane), with or without abemaciclib, for no more than 18 months
Treatment is being conducted at the Institute of Oncology Ljubljana
Has mandatory health insurance through the Health Insurance Institute of Slovenia
Understands Slovenian language
Provides written informed consent to participate in the study
You will not qualify if you...
Metastatic hormone receptor-positive, HER2-negative breast cancer
Previous treatment for breast cancer with an aromatase inhibitor, with or without a CDK4/6 inhibitor, for early breast cancer prior to the current adjuvant treatment line
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 6 months
Participants who are receiving adjuvant therapy with an aromatase inhibitor, with or without abemaciclib, are observed to assess medication adherence, quality of life, cognitive functioning, and beliefs about their therapy.
Visits at Baseline, Month 3, and Month 6
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study.